MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-1200-S

Device Problems Charging Problem (2892); Wireless Communication Problem (3283)

Patient Problems Scar Tissue (2060); Electric Shock (2554)

Event Date 11/17/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced charging/communication difficulties with their deep brain stimulation (dbs) device in addition to experiencing tightness around the dbs lead extensions area.The physician had difficulties connecting his clinician programmer to the ipg and noted the patient experienced a shock from their electric fence.The physician assessed tightness felt in the neck was from scar tissue around the implant site and lead extensions.The patient underwent a procedure were the ipg and lead extensions were replaced.No further information has been provided despite good faith efforts.

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(4), batch: (b)(4).Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(4), batch: (b)(4).

• Brand Name: VERCISE GEVIA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15960771
• MDR Text Key: 305280759
• Report Number: 3006630150-2022-06938
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: 08714729984443
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/06/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 739612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male